Irregular Menstruation Clinical Trial
— (MenoMind)Official title:
The Effect of Online Cognitive Awareness-Based Nursing Support for Premenopausal Women on Vasomotor Symptoms, Stress and Quality of Life
| Verified date | March 2024 |
| Source | Bandirma Onyedi Eylül University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This randomized controlled study was conducted at Istanbul University-Cerrahpaşa Cerrahpaşa Medical Faculty Hospital between 16.05.2022-30.06.2023. Research data were collected at the gynecology outpatient clinic. The sample of the study consisted of 74 (37-intervention, 37-control) premenopausal women who met the inclusion criteria and were placed by randomization. The data of the study were collected using "Personal Information Form, Mindful Attention Awareness Scale (MAAS), Visual Analogue Scale for Vasomotor Symptoms (VAS), Perceived Stress Scale (PSS) and Menopause-Specific Quality of Life Scale (MENQOL)". First, the pretests of the study were applied to women in the intervention and control groups. Afterwards, women in the intervention group underwent the MenoMind program for eight weeks, and women in the control group were left with routine clinical care. In the eighth week of the research, the "MenoMind Evaluation Form" was applied to the women in the intervention group to evaluate the MenoMind program. One month after the study was completed, post-tests were performed on the intervention and control groups.
| Status | Completed |
| Enrollment | 74 |
| Est. completion date | December 12, 2023 |
| Est. primary completion date | June 30, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 40 Years and older |
| Eligibility | Inclusion Criteria: - Being able to read and write, - Being able to use the internet, - Having a device that can use the internet (such as a smartphone or computer), - Not having a diagnosed psychiatric disease, - Not having a chronic disease - Not using hormone replacement therapy, - Age 40 and above and having symptoms of menstrual irregularity, - Receiving an average score of two or more from Menopause-Specific Quality of Life Scale, - Scoring three or more on the Visual Analogue Scale for Vasomotor Symptoms Exclusion Criteria: - There are situations that prevent the exercises from being performed, - Participating in a mindfulness training program before. |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Istanbul University-Cerrahpasa Cerrahpasa Medical Faculty Hospital between | Istanbul |
| Lead Sponsor | Collaborator |
|---|---|
| Bandirma Onyedi Eylül University |
Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Personal Information Form | The personal information form, created in line with the literature, aims to determine the socio-demographic characteristics of women in the premenopausal period; It is a form consisting of 13 items containing descriptive information specific to the individual (age, education, marital status, employment status, income level, vasomotor symptoms, smoking status and regular exercise status). | 5th minute | |
| Secondary | Mindful Attention Awareness Scale (MAAS) | MAAS was developed by Brown and Ryan in 2003. The scale is a six-point Likert type (1 - almost always, 4 - almost never) and consists of 15 items. A single total score is obtained in MAAS. The lowest score that can be obtained from the scale is 15 and the highest score is 90. | 5th minute | |
| Secondary | Visual Analog Scale for Vasomotor Symptoms (VAS) | VAS allows numerical measurement of values that cannot be measured numerically. These parameters are written at both ends of a 100 mm line to determine the severity of hot flashes, sweating and night sweats. The woman is asked to indicate the suitability of her situation by pointing, drawing a line, or placing a dot on this line. By choosing the appropriate value for women, the severity of hot flashes, night sweats and sweating are determined. Evaluation of VAS is made by taking the average of the scores obtained. | 2th minute | |
| Secondary | Perceived Stress Scale (PSS) | PSS, Cohen et al. It was developed by in 1983. The five-point Likert type scale (0 - never, 4 - very often) consists of 14 items. The scale has two subscales. Perception of stress/discomfort (questions 1, 2, 3, 7, 11, 12, 14) and perception of insufficient self-efficacy (questions 4, 5, 6, 8, 9, 10, 13). The scale has no cut-off point. It is understood that as the score of the scale increases, the person's perception of stress increases. | 5th minute | |
| Secondary | Menopause-Specific Quality of Life Scale (MENQOL) | MENQOL, Hilditch et al. It was developed by in 1996. The Likert type scale consists of 29 items. The scale total is calculated using the average score. The preliminary lowest score that can be obtained from the scale is 0, and the highest score is 6. A score of "0" indicates that there is no problem regarding the issue, a score of "1" indicates that the problem exists but is not disturbing, and scores between "2-6" indicate the severity and increasing degrees of the existing problem. The scale consists of four areas. They are the vasomotor domain (questions 1-3), the psychosocial domain (questions 4-10), the physical domain (questions 11-26) and the sexual domain (questions 27-29). | 10th minute |